Monday, June 14, 2010

Food for Thought

When it comes to food, we're more often like the kids singing "Food, Glorious Food" in the beginning of the musical Oliver! than like the serious legal mavens we pretend to be. As noted earlier, we usually bloviate over the "D" part of the FDCA, not the "F" part.Nevertheless, sometimes food litigation has useful things to say about the drug-and-device stuff that we work on day after day -- our bread-and-butter, if you will.

The Food Liability Law Blog recently posted an interesting item with a real grabber of a title: "Dismissal of 'I Can't Believe it's Not Butter' Claims: Another example of Iqbal/Twombly Succeeding Where Preemption Cannot." Recently, it has often felt as if TwIqbal is a necessary alternative to, or consolation for, Levine. The Food Liability Blog discussed a case, Rosen v. Unilever United States, Inc., 2010 U.S. Dist. LEXIS 43797 (N.D. Cal. May 3, 2010), in which the plaintiff claimed that both the label and advertising for I Can't Believe it's Not Butter are misleading because they hawk a "blend of nutritious oils" when one of those oils is partially hydrogenated oil, which food fascists say isn't nutritious at all.

First the bit about preemption not succeeding. The issue was whether the claims were preempted by the Nutrition Labeling and Education Act (NLEA), 21 USC section 346 et seq and the dormant Commerce Clause. The analysis on this issue is very different from what we see in drug and device cases. (Hence our refusal to say 'We Can't Believe It's Not Preempted.') There is no reference to Levine. Nor should there be. Instead, the court says that regulating food marketing is squarely within historic police powers, citing Farm Raised Salmon Cases, 42 Cal 4th 1077, 1088 (2008). (We blogged about the Farm Raised Salmon cases here and here and other posts referenced therein.) Then the court draws a distinction between the parts of food labelling that are regulated by the NLEA and the parts that are not. It's not like drug labels, where the entire label is subject to the FDA's approval. According to the court, the I Can't Believe it's Not Butter label's listing of ingredients is subject to the NLEA, but the allusion to the "nutritious blend" is advertising in the label, and is subject to state consumer protection laws, not the NLEA. (Query whether calls for heightened food label regulations will expand preemption in that area. But we digress.) Anyway, from the perspective of defense lawyers, the first course here is not so tasty.

But the main course is much more satisfying. When we see TwIqbal on the menu it's as if Pavlov rang the dinner bell and we start to salivate. The court breaks TwIqbal down into the two prongs of (1) substantive fact pleading vs. conclusory blathering, and (2) stating a plausible, rather than merely possible, claim for relief. And then the court proceeds to skewer the Complaint on both prongs. The way it does so is interesting and instructive -- and, we think, worthy of emulation.

What we get is a heaping helping of logic. The court reasons that plaintiff is asserting a categorical syllogism: "For the representation 'blend of nutritious oils' to be true, all constituent oils must be nutritious. One of the constituent oils in the product [partially hydrogenated oil] is not nutritious. Therefore, the product representation is false." Rosen, 2010 U.S. Dist. LEXIS 43797 at *13. (Another quick digression: The court defines "categorical syllogism" by citing Aylett v. Secretary of HUD, 54 F.3d 1560, 1567-68 (10th Cir. 1995). The author of that opinion is Senior Judge Aldisert. We are familiar with Judge Aldisert because he is from our Circuit, the Third. Judge Aldisert has written a book called "Logic for Lawyers." We might start citing that book more often in the future.) The Rosen syllogism breaks down because one non-nutritious ingredient doesn't necessarily mean the blend can't be nutritious. That's merely a conclusion, not a factual assertion, so it flunks TwIqbal.

Maybe we ought to defer to chemists and chefs, but what the court is saying seems to make sense. Vitamin-enriched cardboard (which we think we might've actually eaten this morning) would still contain vitamins, right? This post that you are reading right now might include a lot of mindless twaddle and bad ideas, but if it contains a good idea or two can't we brag about that? (Yes, we know - that's truly a hypothetical.) The Complaint alleged no facts showing that something non-nutritional somehow negated components that are nutritional. The court goes on to say that the Complaint does not even state any facts showing why partially hydrogenated oil is not nutritious. Again, plaintiff serves up pure conclusions.

As for the second prong of TwIqbal … well, in this case it ends up looking pretty similar to the first, except it's heavily seasoned with Latin and more logic. The court espies the fallacies of petitio principii (begging the question), composition (properties of the part must be attributed to the whole), and division (properties of the whole are ascribed to each part) in plaintiff's notion that a blend cannot be nutritious unless every single constituent is nutritious. It's like Wittgenstein on Torts. It's a fancy way of saying 'So what?' to the presence of partially hyrdogenated oil. But it works, so who are we to complain?

And now here comes the dessert: the court dismisses the Complaint with prejudice, because "there is no cure for the lack of logical tie." Id. at *17. Crème brulee with a nice, ever-so-slightly-burnt crust. We have to admit that even a ham-fisted defense lawyer had to wonder a moment about that conclusion. Isn't there some way for the plaintiff to insert some sort of factual allegation that would save the Complaint? But unless there's some morsel of break-through science out there that plaintiff knows about (we sure don't), the court is correct.

As we said recently, not every case is suitable for a Rule 12 motion. Believe it or not, every once in a while a plaintiff alleges something factual and plausible. But it's frustrating when bare-bones, muddle-headed (dare we say, non-nutritious) complaints get by (thereby commencing expensive, assymetrical discovery and possibly setting the table for what's politely called settlement but is really the last letter in the acronym used by Ernst Stavro Blofeld's villainous group that was always out to kill James Bond) because TwIqbal is more often cited than followed. TwIqbal is a test, and the Rosen case is an example where a judge applied that test about as rigorously and logically as possible. Just think if that sort of logic were applied to issues of learned intermediary, causation, and reliance. A lot of plaintiffs' lawyers would be out to lunch - on thin gruel.

1 comment:

A. Rein
said...

I agree that the court has its legal analysis just right, but something troubles me about its analysis of the key turn of phrase. Apparently the label said "blend of nutritious oils." The court reads this as a representation that the blend is nutritious, but as I read it the word "nutritious" modifies the word "oils" in that phrase, and the label thus represents that the constituent oils are nutritious. If the oils are non-nutritious, then, the language is misleading.

The court nevertheless reaches the right conclusion, given that plaintiffs don't plead facts to show that partially hydrogenated oil isn't nutritious. (And you could certainly argue that the language is accurate because, since the rest of the oils are nutritious, the product does indeed contain a "blend of nutritious oils" -- plus one non-nutritious oil.) But I'm bothered by the what looks to me like a misreading of the crucial phrase in a case that turns on the application of the principals of logic to language.

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This blog contains the personal views of the Blogging Team identified below (and of any authors of guest posts) concerning various topics that arise in the defense of pharmaceutical and medical device product liability litigation. Please read the DISCLAIMER about the nature of this blog, and understand that you are accepting its terms, before reading any of the posts here.

Blogging Team

James M. Beck is Counsel resident in the Philadelphia office of Reed Smith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). he wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He can be reached at jmbeck@reedsmith.com.

Stephen McConnell has authored articles and chapters on product liability (though nothing as snappy or authoritative as Beck's book) and has tried drug and device cases that managed to evade the pretrial gauntlet. He is a partner in the Philadelphia office of Reed Smith and can be reached at smcconnell@reedsmith.com.

Michelle Hart Yeary is a seasoned products liability litigator who focuses on attempting to bring order to the chaos that is mass torts, concentrating on the practicalities and realities of defending coordinated and multidistrict litigation. She is counsel in the Princeton office of Dechert LLP and can be reached at michelle.yeary@dechert.com.

John J. Sullivan is a products liability and commercial litigator, having authored articles on mass torts and securities litigation and presented on trial advocacy. He is experienced in mass tort litigation, with a particular emphasis on scientific and regulatory issues, as well as having experience in complex commercial, securities class action and corporate governance litigation. He is a partner in the downtown Manhattan and New Jersey offices of Cozen O'Connor and can be reached at jsullivan@cozen.com.

Eric L. Alexander is a partner in Reed Smith’s Washington office. He has spent almost his entire career representing drug and device companies in product liability litigation from discovery through motions, trials, and appeals, usually on the right side of the v. He is particularly interested in medical and proximate cause and the intersection of actual regulatory requirements and the conduct that plaintiffs allege was bad, which covers quite a bit. He can be reached at ealexander@reedsmith.com.

Steven J. Boranian is a partner in Reed Smith’s San Francisco office, where he focuses his practice on representing drug and medical device companies in product liability and other kinds of litigation. He has handled drug and device matters from pre-litigation demands to appeals and all points in between, with particular interests in “mass” proceedings and class actions, to the extent the latter should ever be allowed in the drug and medical device context. He can be reached at sboranian@reedsmith.com.

Rachel B. Weil is counsel in Reed Smith’s Philadelphia office. Except for a brief, misguided trip to the “dark side,” Rachel has spent her whole career defending drug and device manufacturers in product liability litigation and in government actions arising from such litigation. While she laments the single-plaintiff drug cases of her youth, she loves nothing better than a good mass tort. She can be reached at rweil@reedsmith.com
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